News Releases

Mallinckrodt Receives Patent from U.S. Patent and Trademark Office

DUBLIN--(BUSINESS WIRE)--Aug. 6, 2014--
Mallinckrodt
plc (NYSE: MNK) today announced that on July 29, 2014 the
U.S. Patent and Trademark Office granted the company a new patent
related to MNK-155. The patent, U.S. Patent Number 8,790,694 contains
composition claims directed to unique design, formulation,
pharmacokinetic, and release characteristics of MNK-155 and conveys the
same period of exclusivity as did the patent granted in 2013 for the
company’s product XARTEMIS™ XR (oxycodone hydrochloride and
acetaminophen) Extended-Release Tablets (CII).

MNK-155 is Mallinckrodt’s investigational extended-release oral
formulation of hydrocodone and acetaminophen studied for the management
of moderate to moderately severe acute pain where the use of an opioid
analgesic is appropriate. The release profile of MNK-155 combines
Mallinckrodt-proprietary technology and Depomed’s advanced Acuform®
drug delivery technology.

“With the extended period of exclusivity, we expect MNK-155, like
XARTEMIS XR, to be a durable asset and contributor to our growing
portfolio of brands over the long term,” said Mark Trudeau, President
and Chief Executive Officer, Mallinckrodt. “Receipt of this new patent,
which includes the product’s release profile, underscores our ability to
effectively maximize our partnerships and core formulation capabilities.”

XARTEMIS™ XR is indicated for the management of acute pain
severe enough to require opioid treatment and for which alternative
treatment options are inadequate. Because of the risks of addiction,
abuse, misuse, overdose, and death with opioids, even at recommended
doses, reserve XARTEMIS XR for use in patients for whom alternative
treatment options (e.g., non-opioid analgesics) are ineffective, not
tolerated, or would be otherwise inadequate.

XARTEMIS XR exposes patients and other users to the risks of
opioid addiction, abuse, and misuse, which can lead to overdose
and death. Assess each patient’s risk prior to prescribing
XARTEMIS XR, and monitor all patients regularly for the
development of these behaviors or conditions.

Life-threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may
occur with use of XARTEMIS XR. Monitor for respiratory depression,
especially during initiation of XARTEMIS XR or following a dose
increase. Instruct patients to swallow XARTEMIS XR tablets whole;
crushing, chewing, or dissolving XARTEMIS XR can cause rapid
release and absorption of a potentially fatal dose of oxycodone.

Accidental Exposure

Accidental ingestion of XARTEMIS XR, especially in children,
can result in a fatal overdose of oxycodone.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of XARTEMIS XR during pregnancy can result in
neonatal opioid withdrawal syndrome, which may be life-threatening
if not recognized and requires management according to protocols
developed by neonatology experts. If opioid use is required for a
prolonged period in a pregnant woman, advise the patient of the
risk of neonatal opioid withdrawal syndrome and ensure that
appropriate treatment will be available.

Hepatotoxicity

XARTEMIS XR contains acetaminophen. Acetaminophen has been
associated with cases of acute liver failure, at times resulting
in liver transplant and death. Most of the cases of liver injury
are associated with the use of acetaminophen at doses that exceed
the maximum daily limit, and often involve more than one
acetaminophen-containing product.

CONTRAINDICATIONS

XARTEMIS XR is contraindicated in patients with:

known hypersensitivity to oxycodone, acetaminophen, or any other
component of this product.

significant respiratory depression.

acute or severe bronchial asthma or hypercarbia.

known or suspected paralytic ileus.

WARNINGS AND PRECAUTIONS

XARTEMIS XR contains oxycodone, a Schedule II controlled substance. As
an opioid, XARTEMIS XR exposes users to the risks of addiction, abuse,
and misuse. Abuse or misuse of XARTEMIS XR by crushing, chewing,
snorting, or injecting the dissolved product will result in the
uncontrolled delivery of the oxycodone and can result in overdose and
death. With intravenous abuse, the inactive ingredients in XARTEMIS XR
can result in death, local tissue necrosis, infection, pulmonary
granulomas, and increased risk of endocarditis and valvular heart
injury. Parenteral drug abuse is commonly associated with transmission
of infectious diseases such as hepatitis and HIV.

Serious, life-threatening, or fatal respiratory depression has been
reported with the use of opioids, even when used as recommended. While
serious, life-threatening, or fatal respiratory depression can occur
at any time during the use of XARTEMIS XR, the risk is greatest during
the initiation of therapy or following a dose increase.
Life-threatening respiratory depression is more likely to occur in
elderly, cachectic, or debilitated patients as they may have altered
pharmacokinetics or altered clearance compared to younger, healthier
patients. In patients with significant chronic obstructive pulmonary
disease or cor pulmonale, and patients having a substantially
decreased respiratory reserve, hypoxia, hypercapnia, or preexisting
respiratory depression, XARTEMIS XR may decrease respiratory drive to
the point of apnea.

Hypotension, profound sedation, coma, respiratory depression, and
death may result if XARTEMIS XR is used concomitantly with alcohol or
other central nervous system (CNS) depressants.

The risk of acute liver failure is higher in individuals with
underlying liver disease and in individuals who ingest alcohol while
taking acetaminophen.

The respiratory depressant effects of narcotics and their capacity to
elevate cerebrospinal fluid pressure may be markedly exaggerated in
the presence of head injury, other intracranial lesions, or a
pre-existing increase in intracranial pressure.

Oxycodone may cause severe hypotension particularly in individuals
whose ability to maintain blood pressure has been compromised by a
depleted blood volume, or after concurrent administration with drugs
which compromise vasomotor tone such as phenothiazines.

Due to the potential for acetaminophen hepatotoxicity at doses higher
than 4000 milligrams/day, XARTEMIS XR should not be used concomitantly
with other acetaminophen-containing products.

Hypersensitivity and anaphylaxis associated with use of acetaminophen
have been reported. Clinical signs included swelling of the face,
mouth, and throat, respiratory distress, urticaria, rash, pruritus,
and vomiting.

Due to characteristics of the formulation that cause the tablets to
swell and become sticky when wet, consider use of an alternative
analgesic in patients who have difficulty swallowing and patients at
risk for underlying GI disorders resulting in a small gastrointestinal
lumen. Instruct patients not to pre-soak, lick or otherwise wet
XARTEMIS XR tablets prior to placing in the mouth, and to take one
tablet at a time with enough water to ensure complete swallowing
immediately after placing in mouth.

Opioids diminish propulsive peristaltic waves in the gastrointestinal
tract and decrease bowel motility. Oxycodone may cause spasm of the
Sphincter of Oddi and should be used with caution in patients with
biliary tract disease, including acute pancreatitis.

Since the CYP3A4 isoenzyme plays a major role in the metabolism of
XARTEMIS XR, drugs that alter CYP3A4 activity may cause changes in
clearance of oxycodone which could lead to changes in oxycodone plasma
concentrations.

XARTEMIS XR may impair the mental and/or physical abilities required
for the performance of potentially hazardous tasks such as driving a
car or operating machinery. The patient using this drug should be
cautioned accordingly.

ADVERSE REACTIONS

Serious adverse events may include respiratory depression and
hepatotoxicity.

Pregnancy: Opioids cross the placenta and may produce respiratory
depression and psycho-physiologic effects in neonates. Prolonged use
of XARTEMIS XR during pregnancy can result in withdrawal signs in the
neonate, which can be life threatening.

Breast feeding: Oxycodone is present in human milk and may result in
accumulation and toxicities such as sedation and respiratory
depression in some infants. Acetaminophen is present in human milk in
small quantities.

Pediatrics: Safety and effectiveness in pediatric patients under the
age of 18 years have not been established.

XARTEMIS XR is an extended-release oral formulation of oxycodone
hydrochloride and acetaminophen with immediate-release and
extended-release components. It is not interchangeable with other
oxycodone/acetaminophen products because of differing pharmacokinetic
profiles that affect the frequency of administration. XARTEMIS XR is a
schedule II controlled substance.

Statements in this document that are not strictly historical, including
statements regarding the proposed acquisition, the expected timetable
for completing the Questcor transaction, future financial and operating
results, benefits and synergies of the transaction, future opportunities
for the combined businesses and any other statements regarding events or
developments that we believe or anticipate will or may occur in the
future, may be "forward-looking" statements within the meaning of the
Private Securities Litigation Reform Act of 1995, and involve a number
of risks and uncertainties. There are a number of important factors that
could cause actual events to differ materially from those suggested or
indicated by such forward-looking statements and you should not place
undue reliance on any such forward-looking statements. These factors
include risks and uncertainties related to, among other things: general
economic conditions and conditions affecting the industries in which
Mallinckrodt and Questcor operate; the commercial success of
Mallinckrodt's and Questcor's products, including H.P. Acthar®
Gel; Mallinckrodt's and Questcor's ability to protect intellectual
property rights; the parties' ability to satisfy the merger agreement
conditions and consummate the merger on the anticipated timeline or at
all; the availability of financing, including the financing contemplated
by the debt commitment letter, on anticipated terms or at all;
Mallinckrodt's ability to successfully integrate Questcor's operations
and employees with Mallinckrodt's existing business; the ability to
realize anticipated growth, synergies and cost savings; Questcor's
performance and maintenance of important business relationships; the
lack of patent protection for Acthar, and the possible United States
Food and Drug Administration ("FDA") approval and market introduction of
additional competitive products; Questcor's reliance on Acthar for
substantially all of its net sales and profits; Questcor's ability to
continue to generate revenue from sales of Acthar to treat on-label
indications associated with nephrotic syndrome, multiple sclerosis,
infantile spasms or rheumatology-related conditions, and Questcor's
ability to develop other therapeutic uses for Acthar; volatility in
Questcor's Acthar shipments, estimated channel inventory, and end-user
demand; an increase in the proportion of Questcor's Acthar unit sales
comprised of Medicaid-eligible patients and government entities;
Questcor's research and development risks, including risks associated
with Questcor's work in the areas of nephrotic syndrome and lupus, and
Questcor's efforts to develop and obtain FDA approval of Synacthen™
Depot; Mallinckrodt's ability to receive procurement and production
quotas granted by the U.S. Drug Enforcement Administration;
Mallinckrodt's ability to obtain and/or timely transport molybdenum-99
to its technetium-99m generator production facilities; customer
concentration; cost-containment efforts of customers, purchasing groups,
third-party payors and governmental organizations; Mallinckrodt's
ability to successfully develop or commercialize new products;
competition; Mallinckrodt's ability to achieve anticipated benefits of
price increases; Mallinckrodt's ability to integrate acquisitions of
technology, products and businesses generally; product liability losses
and other litigation liability; the reimbursement practices of a small
number of large public or private issuers; complex reporting and payment
obligations under healthcare rebate programs; changes in laws and
regulations; conducting business internationally; foreign exchange
rates; material health, safety and environmental liabilities; litigation
and violations; information technology infrastructure; and restructuring
activities. Additional information regarding the factors that may cause
actual results to differ materially from these forward-looking
statements is available in (i) Mallinckrodt'sSEC filings, including its
Annual Report on Form 10-K for the fiscal year ended September 27, 2013,
its Quarterly Reports on Form 10-Q for the quarterly periods ended
December 27, 2013 and March 28, 2014; (ii) the SEC filings of Cadence
Pharmaceuticals, Inc., which was acquired by Mallinckrodt on March 19,
2014, including its Annual Report on Form 10-K for the fiscal year ended
December 31, 2013; and (iii) Questcor's SEC filings, including its
Annual Report on Form 10-K for the year ended December 31, 2013 (and the
amendment thereto on Form 10-K/A), its Quarterly Reports on Form 10-Q
for the quarterly periods ended March 31, 2014 and June 30, 2014, and
its Current Report on Form 8-K filed with the SEC on July 10, 2014. The
forward-looking statements made herein speak only as of the date hereof
and none of Mallinckrodt, Questcor or any of their respective affiliates
assumes any obligation to update or revise any forward-looking
statement, whether as a result of new information, future events and
developments or otherwise, except as required by law.